CAMBRIDGE, England--(BUSINESS WIRE)--AstraZeneca and its global biologics research and development arm,
MedImmune, announced today efficacy and safety data for durvalumab from
two separate cohorts of patients with either advanced non-small cell
lung cancer (NSCLC) or advanced head and neck squamous cell carcinoma
(HNSCC) at the European Society for Medical Oncology (ESMO) 2016
Congress.1,2 New data from a comparative study of four PD-L1
diagnostic testing assays in HNSCC were also presented at the meeting.3

David Berman, Senior Vice President, Head of Oncology Innovative
Medicines at MedImmune, said: “We are presenting encouraging early
preliminary data for patients with lung or head and neck cancers at this
year’s congress. From efficacy data for durvalumab monotherapy in
pre-treated patients to the results of our early-phase trials in
combination with novel small-molecule medicines, we have signalled our
commitment to finding treatments for patients with these aggressive
cancers.”

Positive Preliminary Results for Durvalumab in NSCLC and HNSCC

Follow-up results of the Study 1108 Phase I/II trial of durvalumab as
monotherapy in patients with advanced NSCLC showed that patients with
high PD-L1-expressing tumours* had higher objective response rate (ORR)
and overall survival (OS) compared with patients with low or no PD-L1
expression.1 ORR (n=287†) was 25% (95% confidence
interval (CI): 19%-33%) in patients with PD-L1-high tumours (n=154)
versus 6% (95% CI: 3%-12%) in patients with PD-L1-low tumours (n=116).
Estimated six-month OS per line of therapy is indicated in the table
below:

Among all patients in this cohort, durvalumab demonstrated a safety
profile consistent with previous experience.1 The most
frequent treatment-related adverse events (AEs) were fatigue (17%),
decreased appetite (9%), and diarrhoea (9%); 5% of patients discontinued
treatment due to AEs.1

Early results from the Phase Ib/IIa trial (SCORES) assessing the safety
and activity of durvalumab combined with the novel small-molecule STAT3
inhibitor AZD9150 or CXCR2 antagonist AZD5069 in patients with advanced
cancers also showed encouraging anti-tumour activity for the two new
potential medicines in combination.4 Among patients receiving
durvalumab plus AZD9150 (n=11), two patients achieved a partial
response, and five patients demonstrated stable disease.4
Among patients receiving AZD5069 (n=20), one patient demonstrated
complete response, two patients demonstrated partial response, and five
patients demonstrated stable disease.4 Both arms determined
the recommended dose for Phase II trials.4

The most common AEs were thrombocytopenia (64%), ALT/AST increase (46%),
nausea (36%) and neutropenia (36%) among patients receiving AZD9150, and
neutropenia (35%), fatigue (25%), and anaemia, anorexia, nausea or pain
(all 15%) among patients receiving AZD5069.4 One Grade 3
dose-limiting toxicity occurred at the 40 mg/kg dose of AZD5069, and two
similar toxicities were noted at 80 mg/kg.4

Leadership in PD-L1 Testing

AstraZeneca extended its biomarker concordance testing by assessing the
analytical similarities of four commercially available PD-L1 tests.3
The results, which analysed concordance data from 501 commercial HNSCC
tumour samples, demonstrated overall percentage agreement of >85% across
three of the commercially available tests.3 These results are
consistent with previously presented data and advance discussion on the
current challenges associated with multiple PD-L1 assays.3

Durvalumab is an investigational human monoclonal antibody directed
against programmed death ligand-1 (PD-L1) and is designed to help
activate the immune system against tumours.6 Durvalumab
blocks PD-L1 interaction with PD-1 and the costimulatory ligand CD80 on
T cells, which maximizes T-cell activation. By inhibiting PD-L1,
durvalumab helps increase T-cell activity against the tumour to counter
its efforts to evade the immune system.6,7 AstraZeneca is
developing durvalumab as the primary molecule in a combination-focused
approach to empowering the immune system against cancer.8 In
2015, durvalumab received Fast Track Designation for the treatment of
patients with PD-L1-positive metastatic HNSCC,9 and in 2016,
durvalumab was granted Breakthrough Therapy Designation by the US Food
and Drug Administration for the treatment of patients with
PD-L1-positive inoperable or metastatic urothelial bladder cancer whose
tumour has progressed during or after one standard platinum-based
regimen.10

AstraZeneca’s Approach to Immuno-Oncology (IO)

Immuno-Oncology (IO) is a therapeutic approach designed to stimulate the
body’s immune system to destroy tumours.11,12,13 At
AstraZeneca, and MedImmune, our biologics research and development arm,
our IO portfolio is anchored by immunotherapies that have been designed
to overcome anti-tumour immune suppression.7,14 We believe
that IO-based therapies will offer the potential for life-changing
anti-cancer treatments for the vast majority of patients.

We are pursuing a comprehensive clinical trial programme that includes
durvalumab (PD-L1) monotherapy and durvalumab in combination with
tremelimumab (CTLA-4) in multiple tumour types, stages of disease, and
lines of therapy,6 using the PD-L1 biomarker as a
decision-making tool to define the best potential treatment path for a
patient. In addition, the ability to combine our IO portfolio with small
targeted molecules from across our oncology pipeline, and with those of
our partners, may provide new treatment options across a broad range of
tumours.

About AstraZeneca in Oncology

AstraZeneca has a deep-rooted heritage in Oncology and offers a quickly
growing portfolio of new medicines that has the potential to transform
patients’ lives and the Company’s future. With at least six new
medicines to be launched between 2014 and 2020 and a broad pipeline of
small molecules and biologics in development, we are committed to
advance New Oncology as one of AstraZeneca’s six Growth Platforms
focused on lung, ovarian, breast and blood cancers. In addition to our
core capabilities, we actively pursue innovative partnerships and
investments that accelerate the delivery of our strategy, as illustrated
by our investment in Acerta Pharma in haematology.

By harnessing the power of four scientific platforms -- Immuno-Oncology,
the genetic drivers of cancer and resistance, DNA damage response and
antibody drug conjugates – and by championing the development of
personalised combinations, AstraZeneca has the vision to redefine cancer
treatment and one day eliminate cancer as a cause of death.

About MedImmune

MedImmune is the global biologics research and development arm of
AstraZeneca, a global, innovation-driven biopharmaceutical business that
focuses on the discovery, development and commercialization of small
molecule and biologic prescription medicines. MedImmune is pioneering
innovative research and exploring novel pathways across key therapeutic
areas, including oncology; respiratory, inflammation and autoimmunity;
cardiovascular and metabolic disease; and infection and vaccines. The
MedImmune headquarters is located in Gaithersburg, Md., one of
AstraZeneca’s three global R&D centres, with additional sites in
Cambridge, UK and Mountain View, CA. For more information, please visit www.medimmune.com.

About AstraZeneca

AstraZeneca is a global, science-led biopharmaceutical company that
focuses on the discovery, development and commercialisation of
prescription medicines, primarily for the treatment of diseases in three
therapy areas - Respiratory & Autoimmunity, Cardiovascular & Metabolic
Diseases, and Oncology. The Company is also active in inflammation,
infection and neuroscience through numerous collaborations. AstraZeneca
operates in over 100 countries and its innovative medicines are used by
millions of patients worldwide. For more information please visit: www.astrazeneca.com

Intended audiences

This press release is issued from AstraZeneca Corporate Headquarters in
Cambridge, UK and is intended to provide information about our global
business. Please be aware that information relating to the approval
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2 Segal NH et al. Updated safety and efficacy of
durvalumab (MEDI4736), an anti-PD-L1 antibody, in patients from a
squamous cell carcinoma of the head and neck (SCCHN) expansion cohort.
European Society for Medical Oncology 2016 Congress. To be presented
October 2016.

3 Ratcliffe MJ et al. A comparative study of PD-L1
diagnostic assays in squamous cell carcinoma of the head and neck
(SCCHN). European Society for Medical Oncology 2016 Congress (Poster
abstract). To be presented October 2016.